BPC September 14 update

Immunomedics IMMU buyout by Gilead GILD +98%; ​Marinus MRNS meets late-stage endpoint +64% AH

Price and Volume Movers

Gilead Sciences, Inc. (NASDAQ:GILD) announced that it will acquire Immunomedics (NASDAQ:IMMU) for $88 per share in cash or approximately $21b. Immunomedics shares closed up 98% to $83.65.

Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) announced that its Phase 3 Marigold trial evaluating oral ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy with refractory seizures, met the primary endpoint. Patients given ganaxolone showed a significant 32.2 percent reduction in 28-day major motor seizure frequency, compared to a 4.0 percent reduction for those receiving the placebo (p=0.002). Shares are trading up 64% to $3.46 after hours.

Vaxart, Inc. (NASDAQ: VXRT) shares closed up 47% to $7.78. The company announced that it will initiate enrollment in its Phase 1 COVID-19 vaccine trial later this month. Data from its ongoing hamster challenge study expected in October.

Seattle Genetics, Inc. (NASDAQ:SGEN) shares closed up 15% to $22% on news of a collaboration with Merck (NYSE:MRK) to develop and commercialize Seattle Genetics' ladiratuzumab vedotin, currently in Phase 2 clinical trials for breast cancer and other solid tumors. Seattle Genetics will receive a $600m upfront payment and Merck will make a $1.0b equity investment of 5m million shares at a price of $200 per share. Seattle Genetics has also granted Merck a license to commercialize tucatinib, for the treatment of HER2-positive cancers outside of the U.S., Canada and Europe. Seattle Genetics will receive $125m upfront.

Mallinckrodt plc (NYSE: MNK) announced that the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1). The CRL stated that, based on the available data, the agency cannot approve the NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1. Shares fell by 8% to close down at $1.10.

89bio, Inc. (Nasdaq: ETNB) announced data from its Phase 1b/2a trial of BIO89-100 in patients with nonalcoholic steatohepatitis (NASH). All dose groups demonstrated significant reductions in liver fat at week 13, with relative reductions up to 60% versus baseline and up to 70% versus placebo, as measured by magnetic resonance imaging – proton density fat factor (MRI-PDFF). Shares closed up 6% to $36.75. The company followed up the news after hours by announcing an underwritten public offering of 3m shares.

Novus Therapeutics, Inc. (NASDAQ:NVUS) shares are trading up 147% after hours to $0.94 on news it has completed the acquisition of Anelixis Therapeutics, Inc, a privately held biotechnology company developing treatments for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases. Novus also announced a private placement for gross proceeds of $108m.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Cassava Sciences, Inc. (SAVA): $7.75; +133%.

Mersana Therapeutics, Inc. (MRSN): $24.17; +30%.

NantKwest, Inc. (NK): $8.09; +23%.

Bicycle Therapeutics plc (BCYC): $19.08; +22%.

Genocea Biosciences, Inc. (GNCA): $2.59; +19%.

DECLINERS:

Harmony Biosciences Holdings, Inc. (HRMY): $39.82; -10%.

Kala Pharmaceuticals, Inc. (KALA): $7.99; -9%.

X4 Pharmaceuticals, Inc. (XFOR): $7.19; -9%.

Annexon, Inc. (ANNX): $23.09; -7%.

SCYNEXIS, Inc. (SCYX): $4.86; -6%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

EBS – Emergent Biosolutions Inc.
Covid-19 vaccine
COVID-19 Vaccine

Phase 1 Phase 1 enrollment to commence September 2020.
$5.3 billion

ERYP – Erytech Pharma S.A.
Eryaspase (Trybeca-1)
Pancreatic cancer

Phase 3 Phase 3 interim superiority analysis expected around end of 2020; final analysis due 2H 2021.
$135.4 million

ETNB – 89bio Inc.
BIO89-100
Nonalcoholic steatohepatitis (NASH)

Phase 1/2 Phase 1b/2 data released September 14, 2020. All dose groups demonstrated significant reductions in liver fat at week 13.
$430.3 million

FBIO – Fortress Biotech Inc.
CAEL‐101
AL amyloidosis

Phase 3 Phase 3 initiation announced September 14, 2020.
$420.7 million

IFRX – InflaRx N.V.
IFX-1
COVID-19

Phase 3 Phase 3 trial initiation announced September 14, 2020.
$126.1 million

INCY – Incyte Corporation
Baricitinib and remdesivir (ACTT-2)
COVID-19

Phase 3 Phase 3 trial met primary endpoint - September 14, 2020. One-day reduction in median recovery time.
$19 billion

KALV – KalVista Pharmaceuticals Inc.
KVD824
Hereditary angioedema

Phase 1 Phase 2 trial to be initiated 2H 2020.
$246.9 million

MNK – Mallinckrodt plc
Terlipressin
Hepatorenal syndrome (HRS) Type 1

CRL CRL announced September 14, 2020.
$115.9 million

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)

Phase 3 Phase 3 trial met primary endpoint - September 14, 2020.
$422.8 million

SAVA – Cassava Sciences Inc.
PTI-125
Alzheimer’s disease

Phase 2b Phase 2b trial did not meet primary endpoint - May 15, 2020. Noted improvements in biomarkers of disease pathology September 14, 2020.
$250.9 million

SRPT – Sarepta Therapeutics Inc.
SRP-9003
Limb-girdle Muscular Dystrophy Type 2E (LGMD2E)

Phase 1/2 Phase 1/2 18-month functional results from Cohort 1 to be presented September 28, 2020.
$11.3 billion

SUPN – Supernus Pharmaceuticals Inc.
SPN-830
Motor fluctuations in Parkinson’s disease (PD)

NDA Filing NDA filing announced September 14, 2020.
$1.2 billion